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Class I medical devices and in vitro diagnostics (IVD) need to be registered by the CIBG. CIBG also issues free sales certificates for these products.
A Class I medical device manufacturer or an IVD manufacturer with a registered place of business outside the European Union wanting to place product(s) on the European market, first of all has to designate an 'authorised representative' established in a Member State of the EU.
If your authorised representative has registered place of business in the Netherlands, he will have to get in contact with the CIBG, in order to have your product registered.
